The local effect of 17 hydroxycorticosterone-21-acetate (compound F) on the diagnostic patch test reaction.
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Acetates↗
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Evaluation of a transdermal fentanyl system in yucatan miniature pigs.
Of 18 pigs used on a coronary stent experimental protocol, 6 each received a transdermal fentanyl patch to document the patterns of transdermal fentanyl absorption in swine. This approach was taken to reduce animal use and potentially refine the surgical regimen. The objective of the fentanyl portion of the study was to demonstrate that transdermal fentanyl may be useful in the management of postoperative analgesia in swine. This study sought to document that demonstrable levels of fentanyl are achievable in swine plasma via a transdermal system and to compare the magnitude of these levels to data in other species. This study does not directly correlate plasma fentanyl levels with analgesic efficacy. Plasma fentanyl concentration peaked within 42 h in five pigs and within 48 h in the remaining pig. All pigs had similar absorption patterns; the only difference was in magnitude. One pig reached 0.99 ng/ml at 42 h; the next highest concentration was 0.77 ng/ml at 48 h in a different animal. The peak concentration in the others ranged from 0.38 to 0.71 ng/ml.
Administration, Cutaneous↗
[Results of more than 1800 tuberculin patch tests in orphanages and schools of Vicenza].
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Humans↗
Plasma profiles of transdermal 17 beta-estradiol delivered by two different matrix patches. A four-way cross-over study in postmenopausal women.
The aim of this study was to investigate the systemic bioavailability and plasma profiles of 17 beta-estradiol (CAS 50-28-2, E2) after the application of two types of matrix patches for the transdermal delivery of E2: MenorestTM (the test patch) with delivery rates of 37.5, 50 and 75 micrograms E2/day and a reference patch with a delivery rate of 50 micrograms E2/day. All 3 test patches were identical in composition, achieving different transdermal E2 delivery rates by variations in the surface area (11.0, 14.5 and 22.5 cm2). All 4 patches were each worn by 24 postmenopausal women over a 4-day period (i.e. 96 h), each of the 4 treatment periods being separated by a 7-day wash-out period according to a randomized, 4-way crossover design. Blood samples were collected before and 3, 6, 9, 12, 24, 34, 48, 58, 72, 84, and 96 h after each patch application. Plasma E2 concentrations were determined by a specific direct radioimmunoassay method. The following pharmacokinetic parameters were evaluated: AUC0-96h; Cmax, tmax, Cmin, Caverage. The course of the E2 plasma levels over the total test period (96 h) was relatively constant for all patches. For the test patch, a linear relationship between the pharmacokinetic parameters and the different patch areas (i.e. dosages of 37.5, 50, 75 micrograms E2/d) could be shown (correlation coefficient 0.99). The resulting Cmax values for the patch were: 44.2, 58.3, and 92.1 pg E2/ml, corresponding to Caverage values of 39.5, 45.5, and 70.6 pg E2/ml. The reference patch and the test patch, at a dose of 50 micrograms E2/d, were similar in terms of Cmax, while the Caverage, AUC0-96h and Cmin were significantly higher with the test patch. The systemic bioavailability of the reference patch was comparable to that of the test patch at a dose of 37.5 micrograms E2/d: AUC0-->96h 3017.5 +/- 1312.4 pg/ml.h for the reference patch and 3375.9 +/- 1254.7 pg/ml.h for the test patch. A physical model for the calculation of the course of the E2 levels was used to describe the experimentally determined data. However, in the evening, periodically higher E2 plasma levels were observed for all patches than in the morning. From these results it can be concluded that E2 plasma profiles produced by the test patch are reproducible, and in the physiological range consistent with the early to mid follicular level in the premenopausal woman over 4 days (96 h), correlating with the doses administered (37.5-50-75 micrograms E2/d). Additionally, the systemic bioavailability of the test patch at a dose of 37.5 micrograms E2/d is comparable to that of the reference patch at a dose of 50 micrograms E2/d.
Administration, Cutaneous↗
Acute effect of nicotine patch on gastric emptying of liquid and solid contents in healthy subjects.
The effect of nicotine on gastric emptying remains controversial. Gastric emptying is delayed in chronic smokers after smoking high-dose nicotine cigarettes, but it is unchanged after chewing nicotine gums. No information is available on the effect of transdermal nicotine patches on the gastric emptying of solid and liquid contents in healthy nonsmokers. Our objective was to prospectively evaluate the effect of the nicotine patch on gastric emptying of liquid and solid contents in healthy nonsmokers. Ten healthy nonsmoking volunteers underwent a baseline dual-isotope gastric scintigraphy with [111In]-diethylenetriaminepantaacetic acid (DTPA) and [99mTc]sulfur colloid isotopes to evaluate prospectively the gastric emptying of liquid and solid contents, respectively. The gastric scintigraphy was repeated after placing a transdermal nicotine patch (Habitrol) for 12 hr designed to deliver 14 mg of nicotine per day. Plasma nicotine level was measured prior to baseline gastric scintigraphy and after 12 hr placing the nicotine patch. Plasma nicotine was absent in all subjects at baseline and but was significantly elevated after 12 hr of nicotine patch (P < 0.009). The mean half-emptying times (T1/2) for the gastric emptying of liquids before and after nicotine patch placement were 31.2+/-23.3 and 25.6+/-8.4 min, respectively (P = 0.498). The mean T1/2s for the gastric emptying of solids before and after nicotine patch placement were 70.1+/-34.0 and 59.7+/-31.4 min, respectively (P = 0.202). There was no correlation between the plasma nicotine level and gastric emptying of liquid and solid contents (correlation coefficient = -0.23 and -0.01, respectively). In conclusion, acute transdermal delivery of nicotine does not affect the gastric emptying of solid and liquid contents in healthy nonsmoking subjects.
Administration, Cutaneous↗
Transdermal fentanyl: clinical trial at the University of Colorado Health Sciences Center.
Transdermal fentanyl is a new fentanyl delivery system recently approved by the FDA for use in patients with chronic pain. In an open-label clinical trial, 5 patients with cancer pain were switched to transdermal fentanyl patches. Patients were evaluated with visual analogue scales (VAS) for pain, mood, and pain relief. A Functional Living Index--Cancer and a symptom questionnaire were filled out 2 wk and 4 wk after initiation of transdermal fentanyl patches. After 2 wk of treatment all patients had VAS improvements in pain control. Patients experienced a decrease in constipation, improved appetite, and improved mood. One patient had drowsiness, which limited dose. The improvements in pain control allowed these patients to perform tasks that they had previously not felt well enough to do.
Administration, Cutaneous↗
Transdermal hormone therapy: gels and patches.
Hormone therapy (HT) in the climacteric has a number of beneficial effects including mitigation of climacteric symptoms and prevention of osteoporosis. Administration of HT via the transdermal route avoids hepatic first-pass metabolism and therefore the high plasma levels of estrogen metabolites that are associated with oral administration. Patch formulations have traditionally been the most common form of transdermal HT. However, as patches may be associated with local skin reactions, gel formulations have been developed in an attempt to improve acceptability and compliance with transdermal HT. Patch and gel formulations are equally as effective in treating climacteric symptoms and improving bone mineral density, and the effects are comparable to those achieved by oral HT.
Administration, Cutaneous↗
Delay discounting predicts cigarette smoking in a laboratory model of abstinence reinforcement.
RATIONALE: Higher rates of delay discounting, or impulsive choice, may be related to relapse during abstinence reinforcement interventions for cigarette smoking, and a transdermal nicotine patch may attenuate delay discounting. OBJECTIVE: The objectives of this study are to assess the relation between delay discounting and smoking after nicotine deprivation in a laboratory model of abstinence reinforcement and the effects of a transdermal nicotine patch on discounting and smoking. MATERIALS AND METHODS: Smokers with no self-reported intention to quit were randomly assigned to an active (14 mg) or placebo patch group (n = 15 per group). In each of three sessions, after a 3-h deprivation period, participants completed a delay discounting task, mood, and craving measures and finally engaged in a laboratory model of abstinence reinforcement. Three abstinence reinforcement conditions were presented in counterbalanced order across the three sessions. During the control session, monetary consequences were delivered every 30 s regardless of smoking. During the low (5.00 dollars available) and high (20.00 dollars available) sessions, participants could earn a progressively increasing amount of money for each 30 s period of abstinence. RESULTS: The low and high conditions significantly increased the latency to smoke relative to control and significantly decreased the amount of smoking. The nicotine patch decreased negative affect, but it did not significantly affect delay discounting or smoking. Individuals who smoked during the low and high conditions showed higher rates of discounting. CONCLUSION: The patch did not attenuate delay discounting or smoking after a period of deprivation, but contingencies for abstinence significantly decreased smoking. Higher rates of delay discounting were related to smoking in a model of abstinence reinforcement treatment.
Administration, Cutaneous↗
A multicenter comparison of adhesion, preference, tolerability, and safety characteristics of two transdermal nitroglycerin delivery systems: Transderm-Nitro and Deponit.
One hundred forty-two patients with stable angina were enrolled in a four-week, multicenter, office-based study to compare the adhesion properties, patient preference, and tolerability of two commercially available transdermal nitroglycerin patches. Data from 139 patients were analyzed. Each patient simultaneously wore one 5-mg Transderm-Nitro (TDN) patch and one 5-mg Deponit (DPT) patch. Patients daily recorded the following information in a diary format: number of angina attacks, frequency of sublingual nitroglycerin use, patch adhesion, and problems at the adhesion site or other medical problems. At the end of the study, patients rated their patch preferences based on ease of application and removal, ease of removing backing, overall adhesion, and adhesion under specific conditions, such as showering, swimming, exercise, hot weather, high humidity, and perspiration. They also specified which patch they would choose for their next prescription. Differences in adhesion properties (P less than 0.0001) and tolerability at the site of application favored TDN over DPT. In addition, significantly more patients (P less than 0.0001) specified TDN as their next prescription choice (83% vs 11%).
Adhesiveness↗
Effect of acute ethanol ingestion on prolactin in menopausal women using estradiol replacement.
Epidemiologic studies suggest that women who consume ethanol are at an increased risk for developing breast cancer. Two randomized, crossover studies were performed to examine the effects of ethanol on prolactin in menopausal women using transdermal estradiol. In study 1, transdermal estradiol patches (0.15 mg) were administered to menopausal women (n = 7) the day before ethanol administration. At 8.00 h, the women ingested ethanol (1 ml/kg, 95% ethanol) or an isocaloric carbohydrate drink. Prolactin levels were measured frequently for 6.3 h. Serum ethanol levels reached a broad peak from 40 to 100 min after initiation of ethanol ingestion. Serum prolactin levels were significantly higher after ethanol ingestion than after the isocaloric carbohydrate drink ingestion (p < 0.03). Study 2 was identical to study 1 except that the transdermal estradiol patches were removed after completion of ethanol or carbohydrate ingestion. In study 2, serum prolactin was greater after ethanol ingestion than after carbohydrate ingestion (p < 0.001). In menopausal women using transdermal estradiol, acute ethanol ingestion is associated with an increase in serum prolactin.
Administration, Cutaneous↗
Lasting effects of adolescent nicotine exposure on the electroencephalogram, event related potentials, and locomotor activity in the rat.
Tobacco smoking initiated during adolescence is often associated with rapid onset of dependence and difficulty in maintaining abstinence. Animal models have demonstrated that adolescent nicotine exposure causes cell death and altered neurochemistry in the cortex and hippocampus; however, little is known about the neurophysiological consequences of adolescent nicotine exposure in the adult. The primary objective of this study was to assess the consequences of adolescent nicotine exposure on the adult electroencephalogram (EEG) and event-related potentials. Male Sprague-Dawley rats were administered nicotine (5.0 mg/kg per day) for 5 days between postnatal days 35 and 40 using transdermal nicotine patches. Following 6-7 weeks of nicotine withdrawal, EEG activity and event related potentials were assessed. Motor activity and sucrose preference were also examined during the nicotine withdrawal period. Additionally, a set of rats was exposed to multiple doses of nicotine for a single day to assess nicotine and cotinine blood levels. Transdermal nicotine produced nicotine (88+/-21.5 ng/ml) and cotinine (647.6+/-123.2 ng/ml) levels comparable to those previously reported. Reduced motor activity, decreased 1-4 Hz power in the cortical electroencephalogram, and increased cortical N1 amplitude were observed in nicotine-exposed rats compared to controls. These data demonstrate that transdermal nicotine patches provide an effective and non-invasive nicotine delivery system for the adolescent rat. The combined neurophysiological and locomotor activity changes observed in nicotine-exposed rats demonstrate that adolescent nicotine exposure has lasting neurobehavioral consequences. These changes may be indicative of a lasting 'nicotine abstinence syndrome' characterized by increased arousal, anxiety, or emotionality.
Age Factors↗
Transdermal testosterone delivery: testosterone patch and gel.
Testosterone replacement treatment is usually life-long. Fortunately, testosterone administration is relatively safe and until the age of 50 years few side effects are noted with normal doses of testosterone. After the age of 50 years when prostate disease becomes more prevalent, shorter-acting testosterone preparations, allowing a fast reduction of circulating testosterone levels, may be an advantage. Testosterone has an impact on sexual and non-sexual behaviour and short-acting testosterone preparations may be better suited for the initiation of long-term administration allowing the monitoring of behavioural effects. Testosterone can be delivered to the circulation through the intact skin, both genital and non-genital. Transdermal administration delivers testosterone at a controlled rate into the systemic circulation, avoiding hepatic first pass and reproducing the diurnal rhythm of testosterone secretion and without the peak and trough levels observed with the use of the traditional long-acting testosterone injections. In conclusion, both the testosterone patch and testosterone gel are valuable contributions to androgen replacement treatment meeting the requirements specified for testosterone replacement treatment.
Administration, Cutaneous↗
Endometrial safety of a transdermal sequential estradiol-levonorgestrel combination.
OBJECTIVE: The aim of this 1-year, randomized, multinational, open-label study was to assess the effect on the endometrium of three dosages of estradiol and sequential levonorgestrel, each administered in a novel 7-day transdermal matrix patch. METHODS: A total of 468 postmenopausal women received patches of 15 cm2 (50 micrograms/day estradiol for 2 weeks followed by 50 micrograms/day estradiol-10 micrograms/day levonorgestrel for 2 weeks), 22.5 cm2 (75 micrograms/day estradiol for 2 weeks followed by 75 micrograms/day estradiol-15 micrograms/day levonorgestrel for 2 weeks) or 30 cm2 (100 micrograms/day estradiol for 2 weeks followed by 100 micrograms/day estradiol-20 micrograms/day levonorgestrel for 2 weeks). Each patch was applied for 7 days. RESULTS: Endometrial biopsies were taken before and after 1 year of treatment, with final valid biopsy results being obtained in 399 women. There were two cases of endometrial hyperplasia (one in the 22.5-cm2 and one in the 30-cm2 group). All three doses of this 7-day sequential combined estradiol-levonorgestrel transdermal hormone replacement therapy therefore had excellent endometrial safety. The lowest dose, however, was associated with less bleeding and a somewhat different histological pattern, compared with the two higher doses. All three doses provided a high level of patient satisfaction with the bleeding response. CONCLUSION: Estradiol and sequential levonorgestrel administered in a 7-day transdermal matrix patch for 1 year provide endometrial protection.
Administration, Cutaneous↗
Clinical manifestations of transdermal scopolamine addiction.
Transdermal scopolamine patches have been extensively prescribed for nonspecific dizziness and vestibular disorders. Patient response may be favorable and side effects are generally limited to xerostomia and blurred vision. However, subtle dependency and outright addiction may develop. Tapered reduction and drug elimination will suffice to eliminate the dependency. However, hospitalization may be necessary to treat severe cases of physiological chemical dependency. Long-term use of transdermal scopolamine patches carries a risk of chemical dependency. Prescribing physicians should review and heed the manufacturer's recommended use.
Administration, Cutaneous↗
The use of nicotine replacement therapy during hospitalization.
Recent findings suggest that smokers who are hospitalized experience significant craving for cigarettes. Thus, nicotine replacement therapy (NRT) may be a particularly important tool for use during hospitalization. The goal of this study is to evaluate the utilization of the transdermal nicotine patch and/or nicotine gum by hospitalized smokers. The data represented in this article are from 580 smokers who participated in a study of a motivational intervention for smoking cessation that was delivered during hospitalization. The primary outcome for this analysis was use of NRT during hospitalization. The results revealed that, among the entire sample, only 7.1% of the overall sample used NRT during hospitalization; 6% of the hospitalized smokers used the transdermal nicotine patch, and 1.1% used nicotine gum. Use of NRT was significantly greater among patients who reported that they were doing anything to help themselves quit smoking at the time of admission (OR = 4.1), those who were seriously planning to quit smoking within the next 30 days (OR = 2.36), those who were nicotine dependent (OR = 2.81), and those for whom a physician had ever offered to prescribe NRT (OR = 1.9). The finding that there is a very low rate of NRT use during hospitalization provides important information to hospital-based care providers and smoking cessation intervention planners. Barriers to NRT use among hospitalized patients should be identified, and strategies designed to maximize use when appropriate. The AHCPR Guideline on Smoking Cessation recommends routine use of NRT in health care settings. Further research is needed to determine why NRT use was so low. In addition, these data suggest that efforts to increase NRT use during hospitalization are needed.
Administration, Cutaneous↗
Transdermal nicotine in PD: a randomized, double-blind, placebo-controlled study.
BACKGROUND: An inverse association between cigarette smoking and the risk of idiopathic PD has been found in many epidemiologic studies. The therapeutic and possible neuroprotective effects of nicotine formulations on parkinsonian symptoms are controversial. METHODS: In a 12-week, randomized, double-blind, placebo-controlled trial, the efficacy and tolerability of transdermal nicotine patches as an add-on treatment for cardinal symptoms were evaluated in 32 nonsmoking patients with PD. After a 1-week run-in phase, patients were randomized to receive nicotine patches (containing 17.5 mg nicotine in the first and 35.0 mg nicotine in the second and third weeks) or identically appearing placebo patches. After this treatment, 3 weeks without patch application followed. The same blinded examiner assessed the patients with the Columbia University Rating Scale, the Webster scale, the Schwab-England scale, a timed walking test, with an instrumental test for fine motor skills and hand tremor, and with the Hamilton Depression Scale. RESULTS: No significant drug effects between both groups were observed in any of the scores and quantitative tests. Side effects were mild and comparable in frequency between both groups. CONCLUSIONS: With the dosage and the period of treatment chosen, transdermal nicotine patches are not effective as an add-on treatment for symptoms of PD.
Administration, Cutaneous↗
Anisocoria from transdermal scopolamine.
A transdermal scopolamine patch is an effective medication for relieving motion sickness, treating nausea and vomiting from chemotherapy and decreasing withdrawal side-effects from wearing off opioids. A 14-year-old boy with chronic granulomatous disease and severe infection was admitted to the hospital because of left shoulder aspergillus' infection and pain. The patient required high dose opioid to control the shoulder pain. A unilateral fixed and dilated pupil was noted. We assumed this to be related to the advancing central nervous system aspergillosis. After extensive neurological 'work up', we realized that the anisocoria was related to the transdermal scopolamine patch that we had prescribed for weaning off the opioid.
Adjuvants, Anesthesia↗
Cardiovascular effects of buccal exposure to dermal nicotine patches in the dog: a comparative evaluation.
OBJECTIVE: Safety concerns have been raised over the possible effects of inappropriate exposure to transdermal nicotine patches. This study was initiated to determine whether placement of these products into the mouth could affect cardiovascular function. METHODS: In a series of 10 anesthetized beagle dogs, Nicoderm, Habitrol, ProStep I (Intact), ProStep D (Damaged) transdermal nicotine products or the Skoal Bandit smokeless tobacco plug were placed in the buccal cavity for 5 minutes. Systemic arterial blood pressure and the electrocardiogram were monitored for up to 90 minutes after exposure with blood samples at intervals during the first 10 minutes for plasma nicotine concentration. RESULTS: The systolic and diastolic arterial blood pressures and heart rate increased within 2 minutes of buccal exposure to either the intact or the damaged ProStep nicotine product. Ventricular arrhythmias were observed in 6 of 10 dogs exposed to the intact patch and 7 of 10 dogs exposed to the damaged patch during the period of maximal cardiovascular response. Modest increases in systemic blood pressure and heart rate were seen with the Nicoderm and Habitrol products but not with the Skoal Bandit. The increases in systemic arterial pressure and heart rate occurring after exposure to ProStep were significantly more severe than those observed after Nicoderm and Habitrol. Mean peak nicotine levels of 9.8 microg/mL (ProStep 1), 5.4 microg/mL (ProStep D), 3.4 microg/mL (Habitrol), 2.5 microg/mL (Nicoderm), and 0.12 microg/mL (Skoal Bandit) were detected within 2 to 10 minutes after buccal placement of the product. CONCLUSIONS: Certain transdermal nicotine patches, when applied to a nondermal site such as the buccal cavity for a short period (5 minutes) can rapidly provoke significant cardiovascular alterations (hypertension, tachycardia, and ventricular arrhythmias). The magnitude of the cardiovascular responses occurring after buccal exposure to a product such as ProStep could pose a risk to susceptible individuals.
Administration, Oral↗